The Effect of Vitamin C on GCF Total Oxidant Capacity in Smoker Patients With Periodontitis

The Effect of Vitamin C Supplementation on GCF Total Oxidant Capacity in Smoker Patients With Periodontitis Following Non-surgical Periodontal Therapy. A Randomized Controlled Clinical Trial

The effect of vitamin C supplementation on GCF total oxidant capacity in smoker patients with periodontitis following non-surgical periodontal therapy.

Study Overview

• Status: Recruiting
• Conditions: Vitamin C Deficiency
• Intervention / Treatment: Drug: Vitamin C

Detailed Description

All subjects were screened by comprehensive periodontal examination and full periodontal charts were obtained and full-mouth periapical radiographs were taken using the long cone parallel technique at the time of the initial examination to confirm the diagnosis.

Both groups (smokers with stage III-IV grade B periodontitis) received full mouth scaling and root planing using ultrasonic scaler and hand instruments under local anesthesia, completed over 2 visits. Patients were given careful instruction in self performed plaque control measures: twice daily tooth brushing with a brush and tooth paste and once daily interdental cleaning using triangular wooden tooth picks and/or interdental brushes rinsing with 0.125% Chlorhexidine HCL mouthwash (Hexitol® ) to be used twice daily for 2 weeks. Group II received antioxidant vit C 2 grams / day for four weeks.

Collection of gingival crevicular fluid (GCF) sample:

In both groups, GCF samples were collected at the initial visit and collected again 3 months after non-surgical treatment as follows : at the selected area (the most periodontally affected site), all clinically detected supragingival plaque were removed carefully to minimize contamination of the paper strips by the plaque . The teeth selected were then gently washed with water, and the sites under study were isolated with cotton rolls to prevent contamination with saliva and gently dried with an air syringe . Filter paper strips were placed at the entrance of the crevice and were left in place for 30 secs ) and then placed in plastic eppendorf. Strips with any plaque, saliva, or blood contamination were discarded .The sample from the individual site was stored at -80°C for later processing . GCF was then extracted and assayed for the content of total oxidant capacity.

Quantitation of TOC in GCF:

GCF samples of both groups were assayed using ELISA technique for estimation of the level of total oxidant capacity (TOC) in GCF as follows:

The TOC was extracted from the paper strip by adding 100 μl of phosphate buffer saline to the eppendorf tube then mixed by vortex followed by centrifugation for 10 min at 3000Xg. The supernatant was used for estimation of TOC. For the quantitative determination of human TOC concentrations in GCF, PerOx (TOS/TOC) Immun-diagnostik Assay (ELISA) Kit was used. ELISA is intended for the quantitative determination of the total oxidative status/capacity (TOS/TOC) in Ethylene-diaminetetraacetic acid (EDTA)-plasma, serum and cell culture supernatants.

The determination of the peroxides is performed by the reaction of a peroxidase with peroxides in the sample followed by the conversion of TMB (Tetra-methylbenzidine) to a colored product. After addition of a stop solution the samples were measured at 450 nm in a microtiter plate reader. The quantification is performed by the delivered calibrator

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: abeer H Sharafuddin, PhD; Phone Number: 00201284181671; Email: abeer.hasan@dentistry.cu.edu.eg
• Study Contact Backup: Name: Abeer H Sharafuddin, PhD; Phone Number: 00201284181671; Email: jabbar480@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Abeer Hassan Sharafuddin
    • Contact: abeer sharafuddin, master; Phone Number: 00201284181671; Email: abeersharafuddin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients were systemically healthy
• stage III-IV grade B periodontitis
• A minimum of two non-adjacent teeth having sites with ≥ 5 mm interdental clinical attachment loss .
• Radiographic bone loss extending to middle third of root and beyond .
• All patients were heavy smokers i.e ≥ 20 cigarettes / day .

Exclusion Criteria:

• patients who had received any periodontal or antibiotic treatment or vitamins supplementation during the last six months.
• pregnant or lactating women
• patients who refused to provide written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental; A Group: Consisted of 20 patients who were treated with scaling and root planing in conjunction with 2g antioxidant Vit (C)	Drug: Vitamin C; antioxidant; Other Names: c retard
NO_INTERVENTION: Control; A Group: consisted of 20 patients who were treated with scaling and root planing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Oxidant Capacity	unit	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival index	score (0 is good no bleeding 3 is worst spontaneous bleeding )	one month
plaque index	score (0 is good no plaque 3 is the worst )	one month
probing depth	mm	one month

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: abeer H Sharafuddin, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 11, 2019
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ANTICIPATED): December 21, 2022

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (ACTUAL): August 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Nutrition Disorders; Hemorrhagic Disorders; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Hemostatic Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Periodontitis; Scurvy; Ascorbic Acid Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 100200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No